quality.

2. Scope

This SOP is applicable to all sterile filling operations involving vials, ampoules, or prefilled syringes conducted in the aseptic filling area of the Sterile Injectable Manufacturing department.

3. Responsibilities

• Machine Operator: Immediately stops the machine and reports any breakage.
• Production Supervisor: Oversees the cleaning, decontamination, and documentation of breakage.
• QA Executive: Assesses impact, ensures proper cleaning, and authorizes re-start of filling.
• Maintenance Personnel: Assists in equipment clearance and resetting post-breakage.

4. Accountability

The Head of Production is accountable for ensuring that all breakages during filling are managed as per SOP and that necessary preventive actions are implemented.

5. Procedure

5.1 Identification of Breakage

1. Operators must visually monitor for vial/ampoule breakages at each stage: feeding, filling, sealing, and unloading.
2. Upon breakage detection, immediately press the emergency stop button.
3. Inform Production Supervisor and QA without delay.

5.2 Isolation and Containment

1. Do not attempt to remove broken containers with bare hands. Use sterile forceps or scoop.
2. Place broken glass and spilled product into a designated yellow-colored biohazard container.
3. If any product contamination is suspected, the line must be declared contaminated until cleared by QA.

5.3 Cleaning and Disinfection

1. Wear full PPE including gloves, face mask, and eye protection.
2. Remove any unbroken containers in the immediate area.
3. Use sterile lint-free wipes soaked in 70% IPA to wipe the affected surface.
4. Use a vacuum cleaner with HEPA filter for removing microglass particles if applicable.
5. Dispose of all cleaning materials as per hazardous waste SOP.

5.4 Quality Assurance Evaluation

1. QA shall evaluate the scope of the incident to determine batch disposition risk.
2. Review prior and subsequent units around the breakage point for integrity and labeling issues.
3. QA shall complete and sign off the Breakage Incident Report (Annexure-1).

5.5 Line Clearance and Re-initiation

1. After complete cleaning, QA shall perform a visual check and record findings in the Line Clearance Log (Annexure-2).
2. Only after QA approval shall the machine be restarted.
3. Document the breakage, its location, quantity, and actions taken in the BMR and Annexure-3.

5.6 Preventive Measures

1. Check alignment of conveyors and guides regularly to avoid container jams.
2. Ensure correct handling of vials/ampoules during feeding.
3. Train operators in safe breakage handling protocols quarterly (Annexure-4).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• BMR: Batch Manufacturing Record
• IPA: Isopropyl Alcohol

7. Documents

1. Breakage Incident Report – Annexure-1
2. Line Clearance Log – Annexure-2
3. Breakage Documentation Log – Annexure-3
4. Operator Training Record – Annexure-4

8. References

• WHO TRS 961 Annex 6 – GMP for Sterile Pharmaceutical Products
• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
• ICH Q9 – Quality Risk Management

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Breakage Incident Report

Date	Batch No.	Breakage Location	No. of Units	Handled By	Remarks
18/06/2025	INJ-3562	Sealing Station	2	Sunil Patil	Minor spill, cleaned

Annexure-2: Line Clearance Log

Date	Batch No.	Area	Cleared By (QA)	Comments
18/06/2025	INJ-3562	Filling Line A	Ritika Joshi	Cleared post-breakage

Annexure-3: Breakage Documentation Log

Date	Batch No.	Stage	Breakage Count	QA Notified	Action Taken
18/06/2025	INJ-3562	Unloading	1	Yes	Cleaned and documented

Annexure-4: Operator Training Record

Name	Department	Training Date	Trainer	Remarks
Vikas Pawar	Production	01/06/2025	QA Executive	Trained on SOP 035

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
20/02/2022	1.0	Initial release	New SOP	QA Head
18/06/2025	2.0	Added training and HEPA cleaning protocol	Periodic Review	QA Head